Counterfeiting medicines is on the rise in the United States and around the globe, putting patients at risk.

Counterfeit medicines are dangerous by their very nature – they are not produced under safe manufacturing conditions and they are not inspected by the regulatory authorities. Therefore, it is impossible for consumers to know what ingredients these products actually contain.

In recent years we have seen a spike in counterfeit medicines in the legitimate medicine supply chain. While the United States is fortunate to have a pharmaceutical distribution system that is generally considered to be among the safest in the world, new cases of counterfeit medicines are emerging every day and Pfizer is not exempt from being targeted.

“Counterfeit medicines pose a serious threat to patient health and safety. Patients who unknowingly purchase counterfeit medicines are denied the therapeutic benefit of the medicines their doctors have prescribed. Counterfeits pose a further risk because they may contain ingredients that are actually harmful. At Pfizer there is no higher priority than ensuring that every patient who purchases a Pfizer medicine receives an authentic product, one that is both safe and effective.” – John Clark, Vice President and Chief Security Officer, Pfizer Global Security

Even in countries generally considered "safe," such as Canada, the United States, and many of the European Union, counterfeit medicines have entered the legitimate supply chain, including counterfeit Lipitor®, Norvasc®, Viagra®, Zithromax®, and Celebrex®. During 2013, authorities from 49 countries seized more than 11.8 million tablets, capsules and vials of counterfeit Pfizer medicines. Many of the raids resulted from leads developed by Pfizer Global Security.

A number of factors have contributed to this rise in criminal counterfeiting activity. Included among them are the growing involvement in the medicine supply chain of under-regulated wholesalers and repackagers, the proliferation of internet pharmacies, advancements in technology that make it easier for criminals to make counterfeit medicines, the increased importation of medicines from Canada and other countries, and the relatively small risk and penalty faced by counterfeiters.

Pfizer believes that there is no higher priority than ensuring that consumers have safe and effective medicines. To realize this goal, both industry and regulators must work cooperatively around the globe to fight counterfeiting and secure the integrity of the pharmaceutical supply chain.

Pfizer has a team of experts who constantly assess new and existing technologies to identify those that will make it more difficult for those who counterfeit our medicines to make convincing copies, and for patients and healthcare providers to distinguish authentic from counterfeit Pfizer medicines.

Recognizing that there is no “catch-all” solution, Pfizer is working closely with the U.S. Food and Drug Administration (FDA) and other regulatory authorities to ensure that pharmaceutical companies have the resources they need to implement the anti-counterfeiting technologies that work most effectively for their products. Pfizer is working collaboratively with wholesalers, pharmacies, customs offices worldwide, and law enforcement agencies to increase inspection coverage, monitor distribution channels, and improve surveillance of distributors and repackagers.

Pfizer has also created a diversified international team to rapidly address product integrity issues as they arise and work proactively to stop them from occurring. The team has focused on putting into place business practices designed to protect patient health, increase cooperation with law enforcement agencies to prosecute counterfeiters, and promote public policy that will help eliminate counterfeiting.

Addressing this rising threat requires a sophisticated, coordinated, and united response. Pfizer recognizes that in addition to its own initiatives, partnerships must be forged across government agencies, the health care community, patients, and third-party stakeholders, to ensure that patients have a safe supply of medicines and that justice is served to those who put patients' lives at risk.

We ask you to join us as a partner in this fight to protect patient safety.

Counterfeit Q & A

Prescription Drug Importation

Prescription Drug Importation

This product information is intended only for residents of the United States.

Background

Prescription drug importation occurs when foreign pharmacies and traders ship medicines, which may or may not be approved for use in other countries, into the U.S. for sale to American consumers. The World Health Organization estimates that more than 50% of prescription medicines that are bought from Internet sites that conceal their physical address are counterfeit,1,2 yet some Members of Congress are considering legislation to allow U.S. consumers to import medicines from countries where they may be cheaper, even though American regulatory controls to ensure that medicines are safe and genuine cannot be imposed on foreign businesses.

Under current law, an individual can import up to a 90-day supply of prescription drugs from Canada for personal use. Large volume importation of prescription drugs could be permitted under current law only if the Health and Human Services (HHS) Secretary was willing to certify that imported drugs "pose no additional risk to the public's health and safety, and result in a significant reduction in the cost of covered products to the American consumer." Recent HHS Secretaries, such as Donna Shalala, Tommy Thompson, and Michael Leavitt, have not been willing to make this certification of "no risk".

Drug Importation

Prescription drug importation raises serious safety concerns due to the difficult task of closely tracking drugs exported to the U.S. to ensure safe handling and to prevent damaged and/or counterfeit (i.e. fake) drugs from being imported into the U.S. and sold to Americans.

The U.S. Food and Drug Administration (FDA), the Drug Enforcement Agency, and the U.S. Customs Service believe that lowering drug importation standards to allow large volume importation could be dangerous and pose an increased risk to public health. In fact, the leading drug safety experts at the FDA agree that drug importation creates an unacceptable risk to the U.S. public. Ten former FDA Commissioners published letters in 2001 stating these opinions.

“Counterfeit medicines are a threat to our communities and must be stopped. This problem is not isolated to a handful of countries; it is present everywhere and it is gaining momentum. It is not a problem of one person, it is a problem of all people. It is not a problem of one country, it is a problem of all nations.” – Dr. Howard Zucker, Assistant Director-General for Health Technology and Pharmaceuticals, WHO

In addition to the serious safety risks of drug importation, the Health and Human Services (HHS) and the Office of Management and Budget (OMB) have stated that prescription drug importation would not result in significant savings for consumers. The HHS Task Force on Drug Importation estimates that administrative costs of a government importation program could reach $3 billion annually and may even result in a net cost for importing drugs instead of providing any savings.3

The success of the Medicare Part D prescription drug benefit is a major reason for the diminished interest by consumers and state governments in drug importation programs. These programs have not succeeded because consumers have largely been well served by Medicare Part D and other patient assistance programs, such as the pharmaceutical industry's Partnership for Prescription Assistance, which are helping eligible Americans get the medicines they need every day. In spite of this, importation continues to receive attention in Congress and in the media.

Federal Legislation

Despite safety concerns and official estimates of little or no savings from a drug importation program, legislation is repeatedly introduced in Congress that would allow commercial importation. For example, on January 10, 2007, Senator Dorgan introduced his latest drug importation bill (S. 242) called the "Pharmaceutical Market Access and Drug Safety Act of 2007".2 The bill would permit drug importation from Canada, Australia, New Zealand, Japan, Switzerland, and some members of the European Union. One of the key safety concerns with the legislation is that commercial drug importation could be extended to other countries without consideration of the prevalence of counterfeit drugs in their supply chain. Additionally, the bill does not include a meaningful mechanism to track the chain of custody of the imported drugs that would provide for appropriate regulation and ensure drug safety.

Additional importation legislation includes a bill passed by Congress in October 2000 called the Medicine Equity and Drug Safety Act. This Act could not be implemented due to public safety concerns. The then-Secretary of HHS, Donna Shalala, determined that HHS could not implement the importation program because neither the safety nor the cost-effectiveness of the Act could be ensured. In July 2001, the then-Secretary of HHS, Tommy Thompson, reached the same conclusion. As a result of these concerns, the federal government did not implement the potentially dangerous legislation.

Over the past decade, a number of bills have been introduced in Congress that would allow commercial drug importation. However no commercial drug importation program has ever been implemented due to serious safety concerns, projected high regulatory costs, and low estimated savings for consumers.

How do you know when you've purchased a counterfeit product?

Consumers may not know that the medicines they've purchased are counterfeits. That's why it's important to purchase prescription products from a pharmacy and pharmacist with whom you're familiar.

In some cases, patients have noticed a different taste, consistency, or appearance of products that are later identified as being counterfeit, or they may have a different reaction to the counterfeit drug.

If you suspect the Pfizer product you have pruchase may be counterfeit, contact us at 1-800-438-1985.

What are the dangers of taking counterfeit products?

One of the biggest concerns is that you may not be getting the therapeutic benefit you expect from the product. For example, a drug you count on to lower your cholesterol level—or to shrink a cancerous tumor—may not be providing any benefit at all because it's counterfeit. Or the product may contain too much active ingredient, which also could be harmful. A fake drug also could interact with other medications you're taking and create potential health issues.

Counterfeit products may be manufactured in substandard environments without appropriate controls that ensure their safety and efficacy and they could contain dangerous contaminants.

Given the present environment in which we live, there also is a concern that counterfeit drugs could be used as a tool by terrorists.

Finally, counterfeit products undermine the basic tenet of our health care system: to enable people to live healthier, happier lives.

How can you avoid buying counterfeit products?

The best way to avoid counterfeit drugs is to purchase prescription medicines at your local pharmacy from a reputable pharmacist whom you know.

Before you fill your prescription online, always see your doctor and get a written prescription first. You should also use an online pharmacy certified by the National Association of Boards of Pharmacy (NABP) when you buy prescription medicines online. This association helps ensure the quality and safety of every online prescription. The NABP’s Verified Internet Pharmacy Practice Sites (VIPPS™) program only certifies pharmacies that meet state licensing and inspection requirements. Use the VIPPS certified pharmacy list to choose a VIPPS™–approved online pharmacy when buying prescription medicines online.

Don't buy medications from online pharmacies that aren't licensed in your country or that offer to write prescriptions or sell medications without prescriptions.

Where available, ask for the product in the manufacturer's original package.

Avoid drugs in foreign packaging because unregulated imports have been a way for counterfeits to enter the U.S. market.

Closely scrutinize the appearance of your medicine and its packaging. Talk to your pharmacist if you notice anything unusual, or if you have a different reaction to your medicine.

Report suspected counterfeiting to the FDA MedWatch Program (or 800-FDA-1088) and to the manufacturer. If you suspect the Pfizer product you have purchased may be counterfeit, contact us at 1-800-438-1985. Remember that if the price of a medicine seems too good to be true, it probably is.

How serious a problem is the counterfeiting of prescription medicines?

The United States has a distribution system that is generally considered to be among the safest in the world.

While the vast majority of the prescription drugs that U.S. consumers buy are safe and effective, counterfeiting is increasingly becoming a more serious problem. The U.S. Food and Drug Administration (FDA) reports that counterfeiting investigations have increased dramatically over the past several years. In 2000 the FDA opened six counterfeit drug cases and in 2004 they opened 58 cases - a nearly ten-fold increase. And it is not just the U.S. that is seeing an increase. In the United Kingdom in 2004, seventeen incidents were reported and in 2005, forty-six; a 270% increase in counterfeiting incidents in one year.

In June 2005, following the discovery that an accredited pharmacy in Canada had dispensed counterfeit Norvasc®, Pfizer’s popular blood pressure medicine – 11 reported deaths were examined for a link to the fakes. The regional coroner reported that of the 11 deaths, the counterfeit medicine could not be ruled out as a cause for four of them. Also in 2005, the United Kingdom saw the recall of medicines from the legitimate supply chain when a counterfeit version of Pfizer’s cholesterol drug Lipitor®(atorvastatin calcium) was found. The resulting nationwide recall of 120,000 packs of the 20 mg Lipitor involved 240 pharmacists. After analysis it was found that approximately 60% of all packs returned were counterfeit.

In 2003, 18 million repackaged Lipitor® tablets – a mix of counterfeit tablets and authentic tablets intended for non-US markets – were recalled from the legitimate supply chain. According to authorities, it was the largest recall of a prescription medicine in the U.S.

It is not just Pfizer whose medicines are being counterfeited. For example, counterfeiters have soaked the labels off vials of a low-strength version of Johnson & Johnson's anemia drug Procrit®, used by cancer patients—and affixed fake labels for the highest strength. And counterfeit vials of the human growth hormone Serostim®, used to treat severe symptoms of AIDS—have been discovered in New Jersey, Texas and Hawaii.

Weaknesses in the drug-distribution system, importation of medicines, the rise of Internet pharmacies, a weak economy, and reductions in health benefits all have contributed to the recent increase in counterfeiting.

The FDA, along with other organizations such as Pharmaceutical Research and Manufacturers of America (PhRMA), Health Distribution Management Association, (HDMA), National Association of Chain Drug Stores (NACDS) and state agencies are actively working to reduce the threat of counterfeiting.

What are the consequences of counterfeiting?

Most importantly, consumers don't get the safe and effective products they pay for and, instead, may be put at significant risk.

On the economic side, legitimate manufacturers of pharmaceuticals suffer from patent and copyright infringement. Counterfeiting, in reality, "hijacks" the brand.

Additionally, counterfeiters take full advantage of the fact that someone else paid the upfront money for research and development expenses; all counterfeiters have to do is to copy the product.

Governments lose as well. Huge amounts of resources are necessary to combat counterfeiting, there is also a negative affect on tax revenues. In fiscal year 2001, U.S. Customs seized over $57 million in counterfeited and pirated products, which represented a significant loss in taxes.

Additionally, health plans are being defrauded.

Counterfeiting is a "lose-lose" situation for consumers, governments, and legitimate manufacturers as well.

What is Pfizer doing to combat the counterfeiting problem?

Because of the threat that counterfeit medicine pose to patients, Pfizer has implemented an aggressive and focused campaign to detect, disrupt and deter major manufacturers and distributors of counterfeit Pfizer medicines.

We initiate investigations and refer the results to enforcement authorities for their action.

We conduct “market surveys”, making test purchases from pharmacies, to monitor the integrity of our medicines sold in the legitimate supply chain.

Through those efforts we have, since 2004, prevented almost 165 million doses of counterfeit Pfizer medicines from reaching patients around the world.

Pfizer continues to explore and implement new technological developments to deter counterfeiting.

The company uses special packaging and printing techniques that make counterfeiting both more difficult to accomplish and easier to spot.

Pfizer also has put in place business practices designed to 1) protect patient health, 2) increase cooperation with law enforcement agencies to successfully prosecute counterfeiters, and 3) promote proactive public policy that will help eliminate counterfeiting.

Pfizer is working with the FDA, wholesalers, the pharmacy community and others to determine how to best keep the American drug distribution system safe for patients.

Pfizer is working with wholesalers, the pharmacy community, and all regulatory and law enforcement agencies, such as the FDA, the British Medicines and Healthcare products Regulatory Agency (MHRA), the Australian Therapeutic Goods Administration (TGA), and others globally to determine how to best keep the drug distribution system safe for patients.

What can be done to improve the situation?

Strengthen accountability within the drug distribution system through tougher enforcement and penalties.

Evaluate and improve, where necessary, the business practices of all those who distribute or dispense prescription medicines.

Employ new technology that has been proven to be effective against counterfeiting. Determine whether increased regulation is needed at both the state and federal levels. Evaluate whether the FDA will need additional resources to deter counterfeiting. FDA collaborative efforts with industry have been a very positive first step.

What can you do to help?

Ask questions and express your concerns about drug counterfeiting, poorly repackaged products, confusing or foreign labeled packs, or any other issues regarding your medication that you do not feel confident in or would like more help from your pharmacist to explain and resolve. Do not leave the pharmacy if you are unhappy, concerned or confused about any aspect of your medicines, the way the medicine is packaged, or the condition of the medicine or packaging.

Consult your doctor or pharmacist and join a patient organization that represents your interests and seek advice from them on your medicine, how it should be packaged, its appearance, the effects of switching to generic or different formulations, and your rights to refuse any medicine you are not confident in or are confused about. Ask about your rights to your standard, long-term medicine packaging. Inform Pfizer in your country that you are not happy - as this allows us to let the authorities know that patients are also concerned.

United States Web sites

BuySafeDrugs.info—PhRMA-sponsored clearinghouse for the latest news, policies, opinion, and research on prescription drug importation that also provides news alerts and information about alternatives to importation.

Safemedicines.org—PhRMA program that provides the basics of medicine safety, precautions to consider when buying medicines online, and tips on how to avoid counterfeit medicines as well as a daily news digest and links to helpful safety resources.

National Intellectual Property Rights Coordination Center—Multi-agency Center responsible for coordinating a unified U.S. Government approach to IPR enforcement issues. Particular emphasis is given to investigating major criminal organizations and those using the Internet to facilitate IPR crime.

Strategy Targeting Organized Piracy (STOP!)—Initiative launched by the USPTO to combat the threat of counterfeit products. Includes a hotline as well as information to leverage the resources of the U.S. Government to secure and enforce trademarks, patents, and copyrights overseas.

United States Food & Drug Administration (FDA)—Government organization responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation; advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

FDA: Combating Counterfeit Drugs—Outline of the FDA's efforts to combat the threat of counterfeit medicines and links to the FDA Counterfeit Report and a discussion of Radio Frequency Identification (RFID) feasibility.

International Web sites

European Alliance for Access to Safe Medicines (EAASM)—An independent, cross-sector patient safety Alliance campaigning for the exclusion of counterfeit and substandard medicines from the supply chain. Raises public awareness of the issues surrounding counterfeit medicines. Pfizer is actively involved as a key Alliance member helping drive initiatives against counterfeit medicines.

International Chamber of Commerce (ICC)—Global business organization serving world business by promoting trade and investment, open markets for goods and services, and the free flow of capital. Get more information on ICC’s IPR efforts. Learn more

Interpol—World’s largest international police organization that provides a range of essential services for the law enforcement community to optimize the international effort to combat crime, including counterfeiting and product integrity issues.

The Third Global Congress on Combating Counterfeiting—Congress convened by Interpol and The World Customs Organization with the support and participation of the World Intellectual Property Organization with the objective to develop a collective understanding of the extent of the counterfeit problem and identify effective measures to combat it.

The Organization for Economic Co–Operation and Development (OECD)—Group of member countries that share a commitment to democratic government and the market economy and work on economic and social issues including development, science, and innovation. Learn more about the multi-year OECD project on counterfeiting and piracy.

World Health Organization (WHO)—United Nations specialized agency for health whose objective is the attainment by all peoples of the highest possible level of health as defined as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.

Additional Resources

Below are resources including brochures and case studies to help you learn more about counterfeiting around the world as well as a checklist to help you avoid, detect, and report counterfeit medicines.

Counterfeit Contents—Medicines can look real, but have counterfeit contents.